Belsomra for insomnia: treatment of sleep difficulties

Belsomra (suvorexant) is a prescription medication taken orally to treat insomnia. It helps adults who have trouble falling asleep or staying asleep, improving overall sleep quality.

Belsomra is approved for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults.

suvorexant

Belsomra works as an orexin receptor antagonist. Orexin is a brain chemical that promotes wakefulness. By blocking orexin receptors, Belsomra reduces wakefulness, helping patients fall asleep and maintain sleep more effectively.

General dosing

• The usual starting dose is 10 mg taken orally no more than once per night, within 30 minutes before bedtime.
• Patients should have at least 7 hours available for sleep after dosing.
• If 10 mg is tolerated but not effective, the dose may be increased to a maximum of 20 mg once nightly.
• The dose should always be the lowest effective amount.

Special considerations

• Taking Belsomra with or shortly after a meal can delay its onset of action.
• Dosage adjustments may be necessary for obese patients and women due to higher exposure; particularly in obese women, increased adverse effects risk should be considered before increasing dose.
• When taken with other central nervous system (CNS) depressants, dose reduction of one or both medications may be needed due to additive sedation effects.
• With moderate CYP3A inhibitors, reduce Belsomra dose to 5 mg once daily; avoid use with strong CYP3A inhibitors.

Belsomra is contraindicated in patients diagnosed with narcolepsy.

CNS depressant effects and daytime impairment

Belsomra can impair daytime alertness and motor coordination, including driving ability. The risk increases with higher doses, especially at 20 mg. Patients should be cautioned about next-day activities requiring full alertness. Dose reductions or discontinuation may be necessary if daytime somnolence occurs.

Worsening of depression and suicidal ideation

There is a dose-related risk of worsening depression and suicidal thoughts. Patients should be monitored closely for these symptoms and evaluated immediately if they arise.

Complex sleep behaviors

Behaviors such as sleepwalking, sleep-driving, or other activities while not fully awake have been reported. These complex sleep behaviors require immediate discontinuation of Belsomra.

Sleep paralysis, hallucinations, and cataplexy-like symptoms

Patients may experience inability to move or speak during sleep-wake transitions, vivid hallucinations, or episodes of sudden muscle weakness. These symptoms increase with dose.

Respiratory function

Caution is advised in patients with compromised respiratory function. Belsomra has not been studied in severe obstructive sleep apnea or severe chronic obstructive pulmonary disease.

Evaluation for co-morbid diagnoses

If insomnia persists beyond 7 to 10 days of treatment, underlying psychiatric or medical conditions should be considered and evaluated.

Common side effects (≥2% and more than placebo)

• Somnolence (7% vs 3% placebo), more frequent in females (8%) than males (3%)
• Headache (7% vs 6% placebo)
• Dizziness (3% vs 2% placebo)
• Abnormal dreams (2% vs 1% placebo)
• Dry mouth (2% vs 1% placebo)
• Cough (2% vs 1% placebo)
• Upper respiratory tract infection (2% vs 1% placebo)
• Diarrhea (2% vs 1% placebo)

Other reported adverse reactions

• Palpitations, tachycardia
• Nausea, vomiting
• Psychomotor hyperactivity
• Anxiety
• Pruritus (itching)

Discontinuation rates due to adverse events

About 3% of patients taking 15 or 20 mg discontinued treatment due to adverse reactions, compared to 5% with placebo; no single event caused discontinuation in ≥1% of patients.

Central nervous system depressants

Concomitant use with benzodiazepines, opioids, tricyclic antidepressants, alcohol, or other CNS depressants increases the risk of sedation and impairment. Alcohol should be avoided during Belsomra treatment due to additive effects.

Cytochrome P450 3A inhibitors

Moderate CYP3A inhibitors require lowering the Belsomra dose to 5 mg daily, not generally exceeding 10 mg. Belsomra is not recommended with strong CYP3A inhibitors.